====== Classifying Minor & Major Nonconformities ======

Before we can classify a nonconformity as a minor or major, we must have a clear understanding of their definitions.

Nonconformity classifications are defined in ISO/IEC 17021-1 for both ISO 9001 & AS9100 audits. AS9101 expands these definitions for AS9100 series audits. However, IMO, AS9101 merely clarifies the vague definitions contained in ISO/IEC 17021-1.

Due to the ambiguous/vague nature of many "requirements" contained in ISO 9001 & AS9100, the auditor must be able to justify each nonconformity (which the auditee may appeal to the CB). Due to the auditor's bias toward a particular interpretation of the standard, far too many auditors "//imagine//" nonconformities where none exist. It is recommended to always refer to the applicable definitions document when interpreting a standard. "//Notes//", whether in the terms and definitions section of a standard or in a vocabulary and definitions document, are NOT requirements.

===== Minor Nonconformities =====

<blockquote>ISO/IEC 17021-1 clause 3.13, Minor nonconformity \\ 
nonconformity that does not affectthe capability of the management system to achievethe intended results.</blockquote>

And
<blockquote>AS9101F, sec. 3.4 Minor Nonconformity \\ 
The requirements of ISO/IEC 17021-1 clause 3.13 apply. \\ 
In addition a minor nonconformity can be a single system failure or lapse in conformity to meet a 9100-series standard requirement, customer QMS requirement, or documented information defined by the organization.</blockquote>


In other words, a nonconformity that is NOT likely to result in the delivery of a nonconforming product or service. Examples of minor nonconformities may include: administrative errors in non-deliverable records or procedures, a lapse in following a procedure that did not impact the deliverable product or service, etc.

===== Major Nonconformities =====

<blockquote>ISO/IEC 17021-1 clause 3.12, Major nonconformity \\ 
nonconformity that affects the capability of the management system to achieve the intended results. \\ 

//Note 1 to entry: Nonconformities could be classified as major in the following circumstances: \\ 
  • if there is a significant doubt that effective process control is in place, or that products or services will meet specified requirements; \\ 
  • a number of minor nonconformities associated with the same requirement or issue could demonstrate a systemic failure and thus 
 constitute a major nonconformity.//</blockquote>

And
<blockquote>AS9101F, sec. 3.3 Major Nonconformity \\ 
The requirements of ISO/IEC 17021-1 clause 3.12 apply. \\ 
In addition, a major nonconformity can be one or more of the following situations: \\ 
• a nonconformity where the effect is judged to be detrimental to the integrity of the product or service; \\ 
• the absence of or total breakdown of a system to meet a 9100-series standard requirement, a customer QMS requirement, or documented information defined by the organization; \\ 
• any nonconformity that can result in the probable delivery of nonconforming product or service; and \\ 
• a condition that can result in the failure or reduce the usability of the product or service and its intended purpose.</blockquote>

As you can see, the threshold for a Major Nonconformance is actually quite low. Consequently, many CBs ask their auditors to provide justification for identifying minor nonconformities that //could// be interpreted as major nonconformities. This justification should identify any factors mitigating the nonconformity from a major to a minor.